Palsonify™

Drug - Palsonify™ (paltusotine) [Crinetics Pharmaceuticals, Inc.]

August 2026

Therapeutic Area - Octreotides & Related

Initial approval criteria

Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
Patient has a diagnosis of acromegaly; AND
ONE of the following:
- Patient had an inadequate response to surgical resection as indicated by growth hormone and serum insulin-like growth factor 1 (IGF-1) that are above the reference ranges; OR
- Patient is not a candidate for surgical resection; OR
- Palsonify will be used in combination with or following pituitary radiation therapy; AND
Palsonify will NOT be used in combination with pasireotide (Signifor LAR); AND
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, oncologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
Prescriber has reviewed Palsonify Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate.

Patient must continue to meet the above criteria; AND
Patient must have clinical benefit with treatment (e.g., decrease in symptom severity/frequency, reduction in tumor size, normalized IGF-1 and/or growth hormone levels); AND
Patient has not experienced any treatment-restricting adverse effects (e.g., complications of cholelithiasis).

Provider Call Center: (844) 575-7887